Fosun Pharma Gains NMPA Approval for Phase I Trial of XS-03 in Advanced Solid Tumors

Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a leading healthcare conglomerate in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, XS-03. This study will focus on evaluating the drug’s efficacy in treating RAS-mutated advanced solid tumors, marking a significant advancement in oncology research.

Mechanism of Action and Therapeutic Potential
XS-03 operates through a unique mechanism, inducing mitotic arrest by inhibiting cell cycle regulatory factors. This action leads to anti-tumor effects, including the suppression of tumor cell proliferation and the promotion of tumor cell apoptosis. Notably, XS-03 exhibits a synthetic lethal effect with KRAS mutations, making it particularly effective against tumor cells carrying these mutations.

Preclinical Success and Global First
Preclinical studies have demonstrated that XS-03 shows significant inhibitory effects on tumor growth across various tumor models, while maintaining a favorable safety profile. Importantly, there is currently no similar small molecule approved globally, positioning XS-03 as a potential first-in-class therapy for patients with RAS-mutated advanced solid tumors.-Fineline Info & Tech

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